Conventional generics today are such reliable matches for branded drugs that pharmacists are often permitted to substitute them in prescriptions on their own. That may not to be the case with the biologics market, in which follow-ons will be "biosimilar," not identical. So some experts doubt biologic follow-ons will ever be as competitive or cheap as today's generics.
That's a point in favor of giving biologic follow-ons a leg up, say by limiting the exclusivity period.
The Federal Trade Commission weighed these issues and concluded in June that the 12-year period was too long -- the cost of developing follow-ons would be so great and their chance of cutting into originators' market share so limited that drug companies would have plenty of incentive to innovate even without it.
The FTC report, which was based on an industry workshop the agency held in 2008, gets cited constantly by the generics industry, so it's not surprising that it drives supporters of Eshoo's bill nuts. When I asked Eshoo about it, she reacted so strongly you'd think I'd bit her in the leg. "It was laughable," she said, "not something done by people who really understand the issues."
What makes this debate more than a sideshow is the amount of money at stake. The drug industry in general isn't shy about scattering cash about in Washington -- a study by the website Maplight.org this week linked Big Pharma's campaign donations to the death of a Senate measure easing the importation of cheap drugs from Canada. Its stepchild, the biotech industry, is a fast learner: It has made roughly $3.8 million in campaign donations since 2003. Eshoo is the top recipient in the House.
No one can be sure how best to spur innovation and competition in the still-novel biologics industry. What we do know is that some of the same arguments heard today in favor of high barriers to generics were mustered against Hatch-Waxman in the 1980s, and the pharmaceutical and generics industry have both thrived. At the moment the 12-year rule is in the healthcare reform bills in both houses of Congress, and the chances are slim it will get a closer look. By the time the lawmakers are done dickering over the big questions, they'll be too exhausted to pay attention to anything else.
Michael Hiltzik's column appears Mondays and Thursdays. Reach him at email@example.com, read his columns $3.8 million in campaign donationsat www.latimes.com/hiltzik, and follow @latimeshiltzik on Twitter.